Labeling of individual units of a 3-pack medical device

andeeezie

Registered
I have developed a resin that I intend to sell in one-time use cartidges. This resin cartidge will be sold only in a 3-pack (1 SKU =3-pack) and not sold individually.

As each cartridge is quite small, do I need to still label each cartidge with all the typical information that I intend to have on the main 3-pack box?

Does each cartridge require a UDI or just one UDI for the 3-pack configuration? The cartidge is likely too small to fit all labeling requirements and a UDI QR code and datastring.

I intended to have the 3-pack box contain all the required labeling, and only print the lot number and the device name on each individual cartidge.

Thank you your input!
 
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